From the blog

A Study of VET3-TGI in Patients With Solid Tumors (STEALTH-001)

Published: June 7, 2024

Primary Outcome Measures

  • Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
  • Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
  • Determine the recommended Phase 2 dose

Secondary Outcome Measures

  • Efficacy assessment: overall response rate (ORR)
  • Efficacy assessment: Duration of response (DOR)
  • Efficacy assessment: disease control rate (DCR)
  • Efficacy assessment: Time to tumor progression (TTP)
  • Efficacy assessment: Progression free survival (PFS)
  • Overall survival
  • Immune changes in tissue and blood
  • VET3-TGI delivery and replication kinetics

Inclusion Criteria

  • Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
  • Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
  • Measurable disease as per RECIST 1.1 criteria
  • At least one tumor amenable to safe ITu injections and/or biopsies
  • ECOG performance status 0 or 1
  • Demonstrate adequate organ function
  • Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions

Exclusion Criteria

  • Prior systemic therapy washout (dependent upon the therapy)
  • Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
  • CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
  • Prior history of myocarditis
  • Known HIV/AIDS, active HBV or HCV infection.
  • Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).
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